Search
Sharan Murugan
May 1, 20242 min read
USFDA Guidance: Considerations for the Use of Human-and Animal-Derived Materials & Recognition and Use of a Standard for Uniform Blood & Blood Component Container Labels
Yesterday (30 April 2024), the FDA released a draft guidance for the industry titled "Considerations for the Use of Human-and...
17 views0 comments
Sharan Murugan
Apr 27, 20242 min read
USFDA Guidance: Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling
Today (29 April 2024), FDA released a new draft guidance for the industry titled "Content and Format of Composition Statement and...
29 views0 comments
Sharan Murugan
Apr 27, 20242 min read
USFDA Guidance: Cancer Clinical Trial Eligibility Criterias
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, Center for Drug Evaluation and Research, and Center for...
8 views0 comments
Sharan Murugan
Apr 27, 20242 min read
USFDA Guidance: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Q&A
On 24 April 2026 (Wednesday) the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research released a...
14 views0 comments
Sharan Murugan
Apr 27, 20242 min read
EMA: Guidance on the Anonymisation of PPD & Assessment of CCI during the preparation of RMPs
The European Medicines Agency (EMA) yesterday (26 April, 2024) released an updated guidance on the "Anonymisation of protected personal...
161 views0 comments
Sharan Murugan
Apr 27, 20242 min read
UK MHRA: Notify MHRA About a Clinical Investigation for a Medical Device
Yesterday (26 April 2024) the UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Notify MHRA About a...
7 views0 comments
Sharan Murugan
Apr 22, 20242 min read
Swiss Medic: Guidance on GMP compliance by Foreign Manufacturers & Application Establishment Licence for Medicinal Products
This Monday (24 April 2024) Swissmedic, updated its guidance on "GMP compliance by Foreign Manufacturers" and "Application establishment...
13 views0 comments
Sharan Murugan
Apr 22, 20242 min read
UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation
Yesterday (22 April 2024) the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance "Medicines: apply for a...
85 views0 comments
Sharan Murugan
Apr 20, 20242 min read
WHO Guidance: GMP in Preventing and Controlling Nitrosamine Contamination in Pharmaceuticals
Earlier this week, the World Health Organization (WHO) released draft guidelines "WHO Good Manufacturing Practices Considerations for the...
37 views0 comments
Sharan Murugan
Apr 20, 20242 min read
MDCG Guidance: In-Vitro Diagnostic Medical Device Safety Reporting
The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Safety reporting in performance studies of...
8 views0 comments
Sharan Murugan
Apr 16, 20242 min read
EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making
On 12 April 2024 the European Medicines Agency released "Guidance on real-world evidence provided by EMA: support for regulatory...
33 views0 comments
Sharan Murugan
Apr 16, 20242 min read
UK MHRA: Rolling Review for MAA and 150-Day Assessment for National Applications
Earlier today (16 April 2024) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on "Rolling Review for...
170 views0 comments
Sharan Murugan
Apr 13, 20242 min read
EMA: Guidance on the Pharmaceutical Quality of Inhalation & Nasal Medicinal Products
Yesterday (12 April 2024) the European Medicines Agency released new guidance on "The Pharmaceutical Quality of Inhalation & Nasal...
62 views0 comments
Sharan Murugan
Apr 13, 20242 min read
UK MHRA Guidance: Borderlines with Medical Devices & Other Products in Great Britain
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Borderlines with Medical Devices & Other Products...
19 views0 comments
Sharan Murugan
Apr 7, 20242 min read
Switzerland's SwissMedic: Guidance on Export Certificates
On 3rd April, 2024 Switzerland's Swissmedic released an updated "Guidance on Export Certificates" and as part of its regulatory...
51 views0 comments
Sharan Murugan
Apr 7, 20242 min read
Ireland HPRA: Submitting a Request for Ireland to Act as RMS in a Decentralised Procedure
Irelands Health Products Regulatory Authority (HPRA) released updated guidance on "Submitting a Request for Ireland to Act as RMS in a...
23 views0 comments
Sharan Murugan
Apr 4, 20242 min read
USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies
Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...
25 views0 comments